In this study, roflumilast showed a trend toward reducing exacerbation rates in patients. 18 Two Phase III, 6-month, randomized, double-blind, placebo-controlled, multicenter trials assessed the benefit of adding roflumilast to long-acting bronchodilators in patients with moderate-to-severe COPD. 29 In the first study, 933 patients were randomized to receive roflumilast 500 μg plus salmeterol (long-acting beta agonist [LABA]) or placebo plus salmeterol, while 743 patients in the second study were randomized to receive roflumilast 500 μg plus tiotropium or placebo plus tiotropium.
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